Intuitive Surgical Careers

Manufacturing Engineering Manager

US-CA-Sunnyvale, California
Manufacturing & Operations

Job Description

Job: Manufacturing & Operations
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 190057


Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

Lead a team of Manufacturing Engineers in the creation and/or integration of efficient “mid-volume” manufacturing lines to produce surgical instruments used in minimally invasive robotically assisted surgery. This key technical management role will guide and mentor a talented product development and manufacturing organization in specifying and refining bill of materials (BOMs), work flow processes, supplier selection, assembly tooling design and detailed assembly / test instructions used to manufacture instruments while optimizing reliability, efficiency, capacity, and cost.

Roles and Responsibilities:

• Provide technical leadership for Core Instruments Manufacturing organization
• Lead the manufacturing team and partner with other organizations to:
o Project manage product reliability improvements for Core Instruments from concept stage to final implementation
o Identify, design, qualify, document and introduce assembly/test fixtures and equipment used in production.
o Improve manufacturing process flows of core instrument manufacturing lines to optimize for reliability, efficiency, capacity and cost.
o Manage the performance of manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans.
o Material, process and supplier selection for components/sub-assemblies.
o Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability and lead the implementation efforts for DFX changes.
o Manage manufacturing strategy and production capability for Core Instrument lines to minimize customer backorders.
o Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.
o Provide technical support for failure analysis and root cause investigation of product failures.
• Provide administrative leadership / control for planning, staffing, budgeting, and project/program cost tracking for Core Instrument portfolio
• Establish group objectives and individual work goals consistent with overall product development goals:
o Assign tasks, set priorities, establish metrics and track progress
o Assess employee performance and provide coaching to improve performance
• Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary.
• Provide budget estimates for product, process improvements, prototype materials, tooling and testing.
• Work with Quality group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements.

Skill/Job Requirements:

• B.S. degree in engineering discipline, M.S. preferred
• Prior responsibility for validation/verification of processes, equipment and products.
• Strong technical analytical skills including (p)FMEA, tolerance analysis, and statistical methods
• Prior responsibility in decision making for component manufacturing processes (machining , injection molding & MIM, stamping, coining, extrusion)
• Familiar with mechanical CAD software (Solidworks).
• Good organizational skills. Ability to work on several fast-paced projects simultaneously.
• Prior experience with managing product, process changes is a plus
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
• Ability to motivate, guide, and inspire members of the core and extended project team. (technicians, purchasing, planning, engineering, regulatory, quality)
• Able to communicate effectively and professionally with customer, suppliers, and other people outside the company.
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
• Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.